FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770410668
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E4361
Catalog number
E4361
Device description
DILATOR MEDIUM TAPER WILDER
Published
2024-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HNWDilator, Lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770410668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770410668007577704106687577704106680757770410668

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal dilator, reusableA hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
196603781
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10757770229908SoFlex® SE IOLLI61SELI61SE22002024-05-21
10757770096746PMMA (P359UV)P359UV2R0002015-09-17
10757770096760PMMA (P359UV)P359UV2R0102015-09-17
10757770096784PMMA (P359UV)P359UV2R0202015-09-17
10757770096807PMMA (P359UV)P359UV2R0302015-09-17
10757770096821PMMA (P359UV)P359UV2R0402015-09-17
10757770096845PMMA (P359UV)P359UV2R0502015-09-17
10757770096869PMMA (P359UV)P359UV2R0602015-09-17
10757770096883PMMA (P359UV)P359UV2R0702015-09-17
10757770096906PMMA (P359UV)P359UV2R0802015-09-17
10757770096920PMMA (P359UV)P359UV2R0902015-09-17
10757770096944PMMA (P359UV)P359UV2R1002015-09-17
10757770096951PMMA (P359UV)P359UV2R1052015-09-17
10757770096968PMMA (P359UV)P359UV2R1102015-09-17
10757770096975PMMA (P359UV)P359UV2R1152015-09-17
10757770096982PMMA (P359UV)P359UV2R1202015-09-17
10757770096999PMMA (P359UV)P359UV2R1252015-09-17
10757770097002PMMA (P359UV)P359UV2R1302015-09-17
10757770097019PMMA (P359UV)P359UV2R1352015-09-17
10757770097026PMMA (P359UV)P359UV2R1402015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421823MillenniumAvalign Technologies, Inc.HNW2026-06-24
04251047934155Gerten Dilator for the Easy Liquid Bubble DMEKA1 Medical GmbHHNW2026-06-09
00810158214538PRINCETONPrinceton Medical Group, Inc.HNW2026-04-21
00840319758892Hayden MedicalHayden Medical, Inc.HNW2026-03-31
00041533986560Bruder KarpeckiThe Hilsinger Company Parent, LlcHNW2025-11-21
00190776411619MillenniumAvalign Technologies, Inc.HNW2025-09-24
00194613010836MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010867MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010874MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613051501MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613083168MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00190776400873MillenniumAvalign Technologies, Inc.HNW2025-06-05
G412PH60850MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH6085T0MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60860MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60870MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60880MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60890MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60900MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60910MR PHACOCrestpoint Management LimitedHNW2025-05-27
00810158215191PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
00810158215207PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
00810158215214PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
G2231132500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNW2025-05-13
00810158215078PRINCETONPrinceton Medical Group, Inc.HNW2025-05-06
00194613010904MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-03-21
00810158214514PRINCETONPrinceton Medical Group, Inc.HNW2025-03-13
00810158214521PRINCETONPrinceton Medical Group, Inc.HNW2025-03-13
00840183529758BR Surgical, LLCBR Surgical, LLCHNW2025-02-14
00810158214194PRINCETONPrinceton Medical Group, Inc.HNW2025-01-27